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Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings : An Expert Consensus

Dittrich, Sabine (author)
FIND, 9 Chemin Mines, CH-1202 Geneva, Switzerland.
Tadesse, Birkneh Tilahun (author)
FIND, 9 Chemin Mines, CH-1202 Geneva, Switzerland.;WHO, Special Programme Res & Training Trop Dis TDR, Ave Appia 20, CH-1211 Geneva 27, Switzerland.;Hawassa Univ, Dept Pediat, Coll Med & Hlth Sci, Hawassa, Ethiopia.
Moussy, Francis (author)
WHO, 20 Ave Appia, CH-1211 Geneva 27, Switzerland.
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Chua, Arlene (author)
Tan Took Seng Hosp, Inst Infect Dis & Epidemiol, Singapore, Singapore.
Zorzet, Anna (author)
Uppsala universitet,Institutionen för medicinska vetenskaper
Tängdén, Thomas (author)
Uppsala universitet,Institutionen för medicinska vetenskaper
Dolinger, David L. (author)
FIND, 9 Chemin Mines, CH-1202 Geneva, Switzerland.;WHO, 20 Ave Appia, CH-1211 Geneva 27, Switzerland.;Tan Took Seng Hosp, Inst Infect Dis & Epidemiol, Singapore, Singapore.
Page, Anne-Laure (author)
Epicentre, Epidemiol & Populat Hlth, Paris, France.
Crump, John A. (author)
Univ Otago, Ctr Int Hlth, POB 56, Dunedin 9054, New Zealand.;Duke Univ, Duke Global Hlth Inst, Box 90519, Durham, NC 27708 USA.;Duke Univ, Med Ctr, Div Infect Dis & Int Hlth, Box 102359, Durham, NC 27710 USA.
D'Acremont, Valerie (author)
Swiss Trop & Publ Hlth Inst, CH-4002 Basel, Switzerland.;Univ Lausanne, Dept Ambulatory Care & Community Med, Bugnon 44, CH-1011 Lausanne, Switzerland.
Bassat, Quique (author)
Hosp Clin Univ Barcelona, Barcelona Ctr Int Hlth Res CRESIB, ISGlobal, Barcelona, Spain.;CISM, Maputo, Mozambique.
Lubell, Yoel (author)
Univ Oxford, Ctr Trop Med & Global Hlth, Oxford, England.;Mahidol Univ, Fac Trop Med, Mahidol Oxford Trop Med Res Unit, Bangkok, Thailand.
Newton, Paul N. (author)
Univ Oxford, Ctr Trop Med & Global Hlth, Oxford, England.;Lao Oxford Mahosot Hosp, Wellcome Trust Res Unit, Viangchan, Laos.
Heinrich, Norbert (author)
Univ Munich LMU, Med Ctr, Div Infect Dis & Trop Med, Munich, Germany.;German Ctr Infect Res, Munich Partner Site,Leopoldstr 5, D-80802 Munich, Germany.
Rodwell, Timothy J. (author)
FIND, 9 Chemin Mines, CH-1202 Geneva, Switzerland.
Gonzalez, Iveth J. (author)
FIND, 9 Chemin Mines, CH-1202 Geneva, Switzerland.
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FIND, 9 Chemin Mines, CH-1202 Geneva, Switzerland FIND, 9 Chemin Mines, CH-1202 Geneva, Switzerland.;WHO, Special Programme Res & Training Trop Dis TDR, Ave Appia 20, CH-1211 Geneva 27, Switzerland.;Hawassa Univ, Dept Pediat, Coll Med & Hlth Sci, Hawassa, Ethiopia. (creator_code:org_t)
2016-08-25
2016
English.
In: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 11:8
Related links:
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • Acute fever is one of the most common presenting symptoms globally. In order to reduce the empiric use of antimicrobial drugs and improve outcomes, it is essential to improve diagnostic capabilities. In the absence of microbiology facilities in low-income settings, an assay to distinguish bacterial from non-bacterial causes would be a critical first step. To ensure that patient and market needs are met, the requirements of such a test should be specified in a target product profile (TPP). To identify minimal/optimal characteristics for a bacterial vs. non-bacterial fever test, experts from academia and international organizations with expertise in infectious diseases, diagnostic test development, laboratory medicine, global health, and health economics were convened. Proposed TPPs were reviewed by this working group, and consensus characteristics were defined. The working group defined non-severely ill, non-malaria infected children as the target population for the desired assay. To provide access to the most patients, the test should be deployable to community health centers and informal health settings, and staff should require <2 days of training to perform the assay. Further, given that the aim is to reduce inappropriate antimicrobial use as well as to deliver appropriate treatment for patients with bacterial infections, the group agreed on minimal diagnostic performance requirements of >90% and >80% for sensitivity and specificity, respectively. Other key characteristics, to account for the challenging environment at which the test is targeted, included: i) time-to-result <10 min (but maximally <2 hrs); ii) storage conditions at 0-40 degrees C, <= 90% non-condensing humidity with a minimal shelf life of 12 months; iii) operational conditions of 5-40 degrees C, <= 90% non-condensing humidity; and iv) minimal sample collection needs (50-100 mu L, capillary blood). This expert approach to define assay requirements for a bacterial vs. non-bacterial assay should guide product development, and enable targeted and timely efforts by industry partners and academic institutions.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Infectious Medicine (hsv//eng)

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